Simple FactSheet: enfuvirtide (Fuzeon; T-20)

enfuvirtide (Fuzeon; T-20)
a Simple FactSheet from the AIDS Treatment Data Network

||||| Fuzeon is an Entry Inhibitor:

Fuzeon, also known as enfuvirtide or T-20, is an anti-HIV treatment in a new class of drugs called Entry Inhibitors. Entry inhibitors work by blocking HIV from entering into healthy cells and infecting them. Fuzeon is the first entry inhibitor approved to treat HIV.
HIV enters cells in a series of steps: 1) HIV attaches to the cell, 2) HIV binds to the cell, and 3) HIV fuses to the cell. Fuzeon works at the last stage by blocking HIV from fusing to the cell, preventing the virus from entry into a healthy cell. It is also call a fusion inhibitor.

||||| Taking the drug:

Fuzeon is an important part of combination treatment for people who have viruses that have become resistant to other available anti-HIV drugs. Fuzeon is most effective when used with at least two other drugs that your virus is not fully resistant to. Fuzeon should not be taken as your only HIV treatment. Drug resistance tests (genotypic or phenotypic) have been shown to be useful in choosing the most effective treatment regimen for you. See the FactSheets Combination Therapy & Understanding Drug Resistance for more information.
Fuzeon is not approved for use as a part of the first HIV treatment regimen. The Public Health Service HIV treatment guidelines does not recommend Fuzeon as part of the first regimen if you have never taken other anti-HIV drugs.
Unlike other anti-HIV drugs, which are taken by mouth, Fuzeon needs to be injected twice a day. This might be hard for people who don't like needles. Former injection drug users may have concerns about taking Fuzeon if needles and injection are a trigger for addiction.
||||| Trial results:

Fuzeon was approved based on two clinical trials involving nearly 1,000 people who had tried several different treatment combinations but were still unable to fully suppress HIV. Average CD4 cell counts were below 100.
All volunteers were given a carefully selected 3-5 drug combination based on treatment history and HIV genotype resistance tests. Two thirds of volunteers also added Fuzeon.
In study T20-301 (TORO 1), 37% of volunteers adding Fuzeon had viral loads below 400 after 24 weeks, compared to 16% of volunteers not receiving Fuzeon. In study T20-302 (TORO 2), 28% of volunteers adding Fuzeon had viral loads below 400 after 24 weeks, compared to 14% of volunteers without the drug. People receiving Fuzeon had an average CD4 cell count increase of 65-76, compared to an increase of 32-38 for people not receiving Fuzeon.
Both studies found that most people taking Fuzeon were able to maintain their CD4 and viral load levels after 48 weeks.

||||| Dosage:

Fuzeon is taken by injection under the skin (subcutaneous). The approved dose is 90 mg twice a day (about 12 hours apart). For children ages 6 to 16, the dose is based on weight - 2 mg per kg twice a day, with a maximum dose of 90 mg.
Fuzeon comes as a powder that must be mixed with sterile water before injection (vials of sterile water come with the powder). It can take 10 to 15 minutes or longer for the powder to dissolve fully. Many people prepare two doses at the same time, injecting one dose then refrigerating the other for their next injection 12 hours later. Each dose should be used right away, or refrigerated for no longer than 24 hours. You can't prepare several doses in advance. Until mixed, both the powder and the sterile water can be stored at room temperature.
Fuzeon can be injected in the stomach area (abdomen), upper arms, and thighs. Fuzeon should be injected where the skin is loose or fleshy (where you can pinch), so that it goes under the skin and not into muscle. Fuzeon should not be injected into muscles or veins.
Injection sites should be rotated - don't use the same area twice in a row, and don't inject where there's still scar tissue from a previous injection.
Your healthcare provider should spend the time to show you how to self-inject until you are comfortable doing it on your own. The drug will not work if it cannot get into the body the right way. Ask your healthcare provider for information on support groups and additional information if you have questions and concerns. If you are having problems, ask your health care provider to go over the procedures with you again. It may take a few times to learn how to do it right.

||||| Side effects:

Nearly everyone taking Fuzeon experiences injection site reactions (ISRs). These reactions are itching, swelling, redness, pain or soreness, and/or bumps at the site where Fuzeon is injected. Some reactions are temporary, but others persist for weeks or months. Some people gently massage the injection area after injecting or apply a cloth soaked in warm water to the site.
Fuzeon has caused allergic (hypersensitivity) reactions in a few people. Symptoms of an allergic reaction to Fuzeon include difficulty breathing, fever, swollen feet, and blood in your urine. If you have any of these symptoms, contact your doctor immediately.
In studies of Fuzeon, people who took Fuzeon were more likely to get bacterial pneumonia than people taking other HIV drugs. If you have a cough, fever or trouble breathing, contact your doctor immediately.
Other possible Fuzeon side effects include pain or numbness in the feet and legs (peripheral neuropathy), insomnia, depression, loss of appetite, weakness, muscle pain, constipation, and pancreas problems.

||||| Warnings:

No drug interactions for Fuzeon have been reported. Tell your doctor about all of the drugs that you take, including non-prescription medicine and herbs.
Fuzeon is a very expensive HIV drug. Many state AIDS Drug Assistance Programs (ADAPs) do not cover Fuzeon or have limits or restrictions on who can receive it. To find out whether your state ADAP covers Fuzeon, see The Access Project.

Hoffman-LaRoche, the maker of Fuzeon (Fuzeon), has a patient assistance program for people having problems getting the drug. The number to call is (866) 694-6670. Note: the patient assistance program may deny you Fuzeon if you are eligible for ADAP but cannot get Fuzeon through your state ADAP program.

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Last modified: 8/15/2006
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\|\|\|\|\| Fuzeon is an Entry Inhibitor:
Fuzeon, also known as enfuvirtide or T-20, is an anti-HIV treatment in a new class of drugs called Entry Inhibitors. Entry inhibitors work by blocking HIV from entering into healthy cells and infecting them. Fuzeon is the first entry inhibitor approved to treat HIV. HIV enters cells in a series of steps: 1) HIV attaches to the cell, 2) HIV binds to the cell, and 3) HIV fuses to the cell. Fuzeon works at the last stage by blocking HIV from fusing to the cell, preventing the virus from entry into a healthy cell. It is also call a fusion inhibitor.
\|\|\|\|\| Taking the drug:
Fuzeon is an important part of combination treatment for people who have viruses that have become resistant to other available anti-HIV drugs. Fuzeon is most effective when used with at least two other drugs that your virus is not fully resistant to. Fuzeon should not be taken as your only HIV treatment. Drug resistance tests (genotypic or phenotypic) have been shown to be useful in choosing the most effective treatment regimen for you. See the FactSheets Combination Therapy & Understanding Drug Resistance for more information. Fuzeon is not approved for use as a part of the first HIV treatment regimen. The Public Health Service HIV treatment guidelines does not recommend Fuzeon as part of the first regimen if you have never taken other anti-HIV drugs. Unlike other anti-HIV drugs, which are taken by mouth, Fuzeon needs to be injected twice a day. This might be hard for people who don't like needles. Former injection drug users may have concerns about taking Fuzeon if needles and injection are a trigger for addiction.
\|\|\|\|\| Trial results:
Fuzeon was approved based on two clinical trials involving nearly 1,000 people who had tried several different treatment combinations but were still unable to fully suppress HIV. Average CD4 cell counts were below 100. All volunteers were given a carefully selected 3-5 drug combination based on treatment history and HIV genotype resistance tests. Two thirds of volunteers also added Fuzeon. In study T20-301 (TORO 1), 37% of volunteers adding Fuzeon had viral loads below 400 after 24 weeks, compared to 16% of volunteers not receiving Fuzeon. In study T20-302 (TORO 2), 28% of volunteers adding Fuzeon had viral loads below 400 after 24 weeks, compared to 14% of volunteers without the drug. People receiving Fuzeon had an average CD4 cell count increase of 65-76, compared to an increase of 32-38 for people not receiving Fuzeon. Both studies found that most people taking Fuzeon were able to maintain their CD4 and viral load levels after 48 weeks.
\|\|\|\|\| Dosage:
Fuzeon is taken by injection under the skin (subcutaneous). The approved dose is 90 mg twice a day (about 12 hours apart). For children ages 6 to 16, the dose is based on weight - 2 mg per kg twice a day, with a maximum dose of 90 mg. Fuzeon comes as a powder that must be mixed with sterile water before injection (vials of sterile water come with the powder). It can take 10 to 15 minutes or longer for the powder to dissolve fully. Many people prepare two doses at the same time, injecting one dose then refrigerating the other for their next injection 12 hours later. Each dose should be used right away, or refrigerated for no longer than 24 hours. You can't prepare several doses in advance. Until mixed, both the powder and the sterile water can be stored at room temperature. Fuzeon can be injected in the stomach area (abdomen), upper arms, and thighs. Fuzeon should be injected where the skin is loose or fleshy (where you can pinch), so that it goes under the skin and not into muscle. Fuzeon should not be injected into muscles or veins. Injection sites should be rotated - don't use the same area twice in a row, and don't inject where there's still scar tissue from a previous injection. Your healthcare provider should spend the time to show you how to self-inject until you are comfortable doing it on your own. The drug will not work if it cannot get into the body the right way. Ask your healthcare provider for information on support groups and additional information if you have questions and concerns. If you are having problems, ask your health care provider to go over the procedures with you again. It may take a few times to learn how to do it right.
\|\|\|\|\| Side effects:
Nearly everyone taking Fuzeon experiences injection site reactions (ISRs). These reactions are itching, swelling, redness, pain or soreness, and/or bumps at the site where Fuzeon is injected. Some reactions are temporary, but others persist for weeks or months. Some people gently massage the injection area after injecting or apply a cloth soaked in warm water to the site. Fuzeon has caused allergic (hypersensitivity) reactions in a few people. Symptoms of an allergic reaction to Fuzeon include difficulty breathing, fever, swollen feet, and blood in your urine. If you have any of these symptoms, contact your doctor immediately. In studies of Fuzeon, people who took Fuzeon were more likely to get bacterial pneumonia than people taking other HIV drugs. If you have a cough, fever or trouble breathing, contact your doctor immediately. Other possible Fuzeon side effects include pain or numbness in the feet and legs (peripheral neuropathy), insomnia, depression, loss of appetite, weakness, muscle pain, constipation, and pancreas problems.
\|\|\|\|\| Warnings:
No drug interactions for Fuzeon have been reported. Tell your doctor about all of the drugs that you take, including non-prescription medicine and herbs. Fuzeon is a very expensive HIV drug. Many state AIDS Drug Assistance Programs (ADAPs) do not cover Fuzeon or have limits or restrictions on who can receive it. To find out whether your state ADAP covers Fuzeon, see The Access Project. Hoffman-LaRoche, the maker of Fuzeon (Fuzeon), has a patient assistance program for people having problems getting the drug. The number to call is (866) 694-6670. Note: the patient assistance program may deny you Fuzeon if you are eligible for ADAP but cannot get Fuzeon through your state ADAP program.